Clareon PanOptix Pro PXYAT4 (REF PXYAT4.130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380658494612), received between Aug 8, 2025 and Mar 17, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DISPLACEMENT OF OCULAR LENS. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE SURGEON ATTRIBUTED THE EVENT TO THE DISPLACEMENT OF IOL. THE LENS EXCHANGE WAS PERFORMED USING A COMPANY LENS OF SAME MODEL BUT HALF DIOPTER MORE POWER IN THE PATIENT¿S LEFT EYE. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 24617108 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED POOR VISION AND LETTERS TWISTING SIDEWAYS. AFTER A WEEK HIS VISION WAS NOT MUCH BETTER THAN BEFORE AND DOCTOR SAID TO WAIT FOR A MONTH. ADDITIONAL INFORMATION WAS RECEIVED; PATIENT HAD ONLY ONE VISION WITH NO DIFFERENCE IF HE LOOKED DOWN OR FAR AWAY AND CANNOT READ. SPECIALIST SAID TO PATIENT THAT HIS EYE LOOKED GOOD WITH MINOR MACULAR DEGENERATION, LENS MAY BE ROTATED AND EYE DROPS WERE PRESCRIBED. ADDITIONAL INFORMATION WAS RECEIVED, THE SURGEON WHO PERFORMED THE PROCEDURE WANTED TO DO FIELD-OF-VISION TEST AND HE DOES NOT THINK THE LENS WAS ROTATED.

  Patient problems: Blurred Vision; Retinal Degeneration; Visual Impairment

  MAUDE report 23580127 ↗
• InjuryAug 8, 2025Material Discolored; Material Discolored

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE ASTIGMATISM IN RIGHT EYE WAS AT -0.5 DIOPTER AND THE PATIENT MENTIONED THAT HE EXPERIENCED DYSPHOTOPSIA WHILE DRIVING AT NIGHT.

  Patient problems: Blurred Vision; Dry Eye(s); Keratitis; Visual Disturbances; Visual Impairment

  MAUDE report 22749013 ↗